To provide a regulatory perspective on developing new HIV protease inhibitors. The present review highlights the risks and benefits of certain design aspects for studies in treatment-naïve and treatment-experienced patients, including timing of studies, study design options, choice of control arms, and duration of treatment.
The present review highlights published studies to illustrate the need for new therapies and highlights potential historical data to help design future HIV clinical trials better.
New antiretroviral agents for patients with multidrug resistance, including safer, more convenient therapies without significant drug–drug interactions, are still needed for all patients. The goals of therapy have evolved and the expectation for treatment regimens is that the majority of patients, including treatment-experienced patients, will achieve undetectable HIV RNA. New study designs, particularly for treatment-experienced patients, are needed to help identify potential risks and benefits of new treatments.
aOffice of New Drugs, Office of Antimicrobial Products, Division of Antiviral Products, US Food and Drug Administration, USA
bOffice of Biostatistics, Division of Biometrics IV, US Food and Drug Administrations, Silver Spring, Maryland, USA
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